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Completed

NCT Number: NCT02245178

Lung Function Decline and Disease Risk From Young Adulthood to Middle Age

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States, but markers that predict risk of developing disease outside of cigarette smoking have not been identified. Individuals with lung disease frequently have concurrent cardiovascular disease, but the reason for this is not well understood. In this study, we will identify markers that predict risk of future lung disease and evaluate the concurrent subclinical evolution of lung and heart dysfunction. This will allow for targeting of preventive strategies to stop the rising incidence of COPD and other lung diseases and provide insights into why heart and lung disease frequently occur together.

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Key information

About this study

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States. Although smoking is a major risk factor for COPD, only a minority of smokers develops COPD. Markers that predict risk of future COPD in young adults would be valuable to target risk reduction strategies and identify subclinical disease. Although COPD is classically defined by obstructive lung physiology, many individuals, including smokers, have spirometric restrictive physiology. Reduced lung function, whether manifesting as COPD or restriction, is associated with adverse cardiovascular outcomes. Our long-term goals are to identify subclinical manifestations of COPD and other lung disease and explore why heart and lung disease co-exist. This is an ancillary study to the Coronary Artery Risk Development in Young Adults (CARDIA) cohort study's year 30 examination. We will add pre- and post-bronchodilator spirometry to the exam and evaluate the lung parenchymal and vascular structure on cardiac CT scans from year 25. Informed by our preliminary data which documents that markers of systemic inflammation and endothelial dysfunction are associated with subsequent lung function decline in young adults, that lung function decline in young adults is associated with incident hypertension, and that there is a divergence in cardiac structure and function depending on the pattern of lung function decline, we propose the following specific aims: (1) To evaluate factors in young adults that predict incident COPD and/or restriction; (2) To determine whether incident COPD and incident restriction are associated with distinct cardiac structural and functional changes; and (3) To determine the lung structural and intrathoracic vascular changes associated with incident COPD and incident restriction. We will test the hypothesis that early life markers of systemic inflammation and endothelial dysfunction are associated with risk of subsequent lung disease and explore whether different inflammatory markers predict different lung phenotypes. We will then evaluate the cardiac structural changes associated with different lung phenotypes and evaluate the lung structural and pulmonary vascular alterations that may explain the concurrently evolving cardiovascular findings associated with developing lung disease. These studies will describe the subclinical manifestations of lung disease, identify markers that predict risk of future lung disease, and expand our understanding of heart-lung interactions as they evolve from health in young adults to disease in middle age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in the main CARDIA examination at year 30

Exclusion criteria

  • Shortness of breath with pain in the chest within the past week
  • Heart attack or stroke within the past month

Treatment and study plan

Lung spirometry

Procedure

measurement of pulmonary function pre- and post-bronchodilator

Other names: lung function

CT scan analysis

Other

Analysis of existing year 25 thoracic CT scans for lung and intrathoracic vascular structure

Primary outcomes

  1. Incident COPD

    Time frame: 30 years

    From cohort initiation, predictors of incident COPD

Secondary outcomes

  1. Incident restriction

    Time frame: 30 years

    From cohort initiation, predictors of incident restrictive lung physiology

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Brigham and Women's Hospital
  • Kaiser Foundation Research Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Alabama at Birmingham
  • University of Kentucky
  • University of Minnesota
  • Vanderbilt University

Registry information

Acronym: CARDIA Lung

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Sep 19, 2014
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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